Data / Medical devices / United States / Storz Medical America, Inc.

Storz Medical America, Inc.: FDA-registered device maker in Kennesaw, GA, United States, 14 510(k) clearances and 2 PMA approvals

Name: Storz Medical America, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Storz Medical America, Inc. is registered with the FDA (registration 1061158) in Kennesaw, GA, United States. It lists 9 device types. The FDA files 14 510(k) clearances and 2 PMA approvals under its listings, the newest dated May 3, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1061158
FEI number: 1000511585
Address: 1000 Cobb Place BLVD Building 400, Suite 450, Kennesaw, GA, United States, 30144
Owner or operator: STORZ MEDICAL AG (9028780)
Roles: Complaint file establishment
First device listed: December 5, 2007
Registered through: 2026
Brand names listed: CHATTANOOGA Intelect F-SW USA, CHATTANOOGA Mobile 2 RPW USA, D-ACTOR 100, D-ACTOR 200, D-ACTOR 50, DUOLITH SD1 R-SW, DUOLITH SD1 T-TOP, DUOLITH SD1 T-Top and more

Devices it lists

Device	Product code	Class	Role	Source
Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers	PZL	2	Complaint file establishment	accessdata.fda.gov
Generator, Shock-Wave, For Pain Relief	NBN	3	Complaint file establishment	accessdata.fda.gov
Lithotriptor, Extracorporeal Shock-Wave, Urological	LNS	2	Complaint file establishment	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Complaint file establishment	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Complaint file establishment	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Complaint file establishment	accessdata.fda.gov
Vibrator, Therapeutic	IRO	1	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 3, 2021	K203710	Storz Medical MAGNETOLITH Muscle Stimulator	IPF	Substantially Equivalent	Storz Medical AG	accessdata.fda.gov
March 30, 2021	K201001	Modulith SLX-F2	LNS	Substantially Equivalent	Karl Storz Endoscopy America	accessdata.fda.gov
February 21, 2021	K202112	Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece	PZL	Substantially Equivalent	Storz Medical AG	accessdata.fda.gov
December 29, 2020	K200965	XR-MX/1000	JAA	Substantially Equivalent	Karl Storz Endoscopy America, Inc.	accessdata.fda.gov
April 13, 2018	K173692	D-Actor 200 Vibration Massage System	ISA	Substantially Equivalent	Storz Medical AG	accessdata.fda.gov
June 12, 2012	K120769	MODULTH SLK	LNS	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
March 18, 2010	K093603	STORM-BASE 2.0	LLZ	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
December 26, 2007	K072788	STORZ MODULITH LITHOTRIPTER SLX-F2-F180	LNS	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
August 30, 2007	K070579	STORZ SLX-F2 STORM TOUCH	LNS	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
August 26, 2004	K040476	STORZ MODULITH, MODEL SLX-F2	LNS	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
August 16, 2002	K011700	MODULITH SLK LITHOTRIPTER	LNS	Substantially Equivalent	Karl Storz Endoscopy	accessdata.fda.gov
October 16, 2001	K012482	STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION	LNS	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.	accessdata.fda.gov
February 13, 2001	K010340	MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI	LNS	Substantially Equivalent	Karl Storz Lithotripsy-America, Inc.	accessdata.fda.gov
February 2, 2001	K004037	X-RAY SYSTEM XR-MX	JAA	Substantially Equivalent	Karl Storz Endoscopy	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
January 8, 2016	P080028	STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY	NBN	1	February 5, 2020	accessdata.fda.gov
February 17, 1995	P920051	STORZ MODULITH (TM) LITHOTRIPTER	LNS	7	October 31, 1997	accessdata.fda.gov

Compare with other makers

Updated May 3, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.